Correlation, Accuracy, Precision and Practicability of Zero Heat Flux Temperature Monitoring
1 other identifier
observational
120
1 country
1
Brief Summary
Hypothermia is common in patients undergoing general anesthesia. There have been several negative outcomes reported. Zero heat flux is a non-invasive method for measurement of body core temperature. The aim of this study is to see if this method is comparable in terms of correlation, accuracy, precision and practicability to commonly used sublingual and nasopharyngeal temperature monitoring.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 1, 2014
CompletedFirst Posted
Study publicly available on registry
January 9, 2014
CompletedMay 16, 2014
May 1, 2014
2 months
January 1, 2014
May 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
body core temperature (°C)
body core temperature taken at 15 min after induction of anesthesia
Secondary Outcomes (1)
body core temperature (°C)
body core temperature taken at 45 min after induction of anesthesia
Other Outcomes (1)
body core temperature (°C)
body core temperature taken at 75 min after induction of anesthesia
Eligibility Criteria
Patients older than 16 years undergoing elective surgery in either gynecology or trauma surgery with a planned surgery time \> 60 min.
You may qualify if:
- elective surgery in gynecology or trauma surgery
- planned surgery time \> 60 min
- patients older than 16 years
You may not qualify if:
- emergency surgery
- need for post-surgery ventilation
- patient's denial to take part in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Schleswig-Holsteinlead
- 3Mcollaborator
Study Sites (1)
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Anästhesiologie und Operative Intensivmedizin
Kiel, Schleswig-Holstein, 24105, Germany
Related Publications (2)
Teunissen LP, Klewer J, de Haan A, de Koning JJ, Daanen HA. Non-invasive continuous core temperature measurement by zero heat flux. Physiol Meas. 2011 May;32(5):559-70. doi: 10.1088/0967-3334/32/5/005. Epub 2011 Mar 28.
PMID: 21444968BACKGROUNDIden T, Horn EP, Bein B, Bohm R, Beese J, Hocker J. Intraoperative temperature monitoring with zero heat flux technology (3M SpotOn sensor) in comparison with sublingual and nasopharyngeal temperature: An observational study. Eur J Anaesthesiol. 2015 Jun;32(6):387-91. doi: 10.1097/EJA.0000000000000232.
PMID: 25693138DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jan Hoecker, MD
Klinik fur Anästhesiologie und Operative Intensivmedizin
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. Jan Höcker
Study Record Dates
First Submitted
January 1, 2014
First Posted
January 9, 2014
Study Start
October 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 16, 2014
Record last verified: 2014-05